[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535982":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":12,"locations":18,"responsibleParty":33,"collaborators":7,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":7,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":7,"maxAge":7,"enrollmentInfo":43,"targetDuration":46,"studyType":47,"phases":7,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":21,"whyStopped":7,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},{"fullName":5,"class":6},"Ipsen","INDUSTRY",null,[9],{"name":10,"affiliation":5,"role":11},"Ipsen Medical Director","STUDY_DIRECTOR",[13],{"name":14,"role":15,"phone":16,"phoneExt":7,"email":17},"Ipsen Clinical Study Enquiries","CONTACT","See e mail","clinical.trials@ipsen.com",[19],{"facility":20,"status":21,"city":22,"state":23,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":7},"Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program","RECRUITING","Wilmington","North Carolina","28401","United States","US",{"type":28,"coordinates":29},"Point",[30,31],-77.94604,34.23556,{"lat":31,"lon":30},{"type":34,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100535982","odevixibat-pregnancy-and-lactation-surveillance-program-a-study-to-evaluate-the-safety-of-odevixibat-during-pregnancy-andor-lactation-100535982",false,"NCT06258902","Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and\u002For Lactation","Odevixibat Pregnancy and Lactation Surveillance Program: A Post-marketing, Long-term, Observational, Descriptive Study to Assess the Risk of Pregnancy and Maternal Complications and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Odevixibat During Pregnancy and\u002For Lactation","Inclusion Criteria:\n\n* Exposure to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and\u002For at any time during lactation (up to 12 months of infant age or weaning, whichever comes first).\n* Informed consent or IRB-\u002FEC-approved waiver of informed consent (not applicable if reported by Albireo PV according to usual pharmacovigilance practices)\n\nExclusion Criteria:\n\n* Refusal to provide informed consent, if required","FEMALE",{"count":44,"type":45},20,"ESTIMATED","10 Years","OBSERVATIONAL","The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and\u002For at any time during lactation (up to 12 months of infant age or weaning, whichever comes first.\n\nThis study will collect data obtained via a variety of sources, including enrolled pregnant or lactating participants, the healthcare providers (HCP) involved in their care or the care of their infants, if applicable, and Albireo pharmacovigilance.\n\nStudy start date is either start of data collection or first patient enrolled whatever occurs earlier.\n\nThe surveillance program is strictly observational; the schedule of office visits and all treatment regimens are determined by HCPs. Only data that are routinely documented in patients' medical records as part of usual care will be collected.\n\nNo additional laboratory tests or HCP assessments will be required as part of this surveillance program.",[50],"Pregnancy Related",[52,53,54,55],"Rare disease","PFIC","Pregnancy","Lactation","2026-07-01",{"date":58,"type":59},"2026-07-02","ACTUAL",{"date":61,"type":59},"2023-09-28",{"date":63,"type":45},"2032-05-31",{"name":5,"class":6},1]